FDA Urged to Take Enforcement Action against Manufacturers of Dietary Supplements that Promise to Help Smokers Quit

Companies Produce No Evidence to Support their Claims

April 23, 2019

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The Center for Science in the Public Interest is asking the Food and Drug Administration to take enforcement action against 15 manufacturers of dietary supplements that claim to help smokers quit. The nonprofit food and health watchdog says that the claims on these products—both implicit and explicit—that the pills will help ease nicotine withdrawal or otherwise help smokers quit tobacco mean that the FDA should classify the products as unapproved new drugs. The FDA should ask the companies to withdraw the claims and products and authorize its inspectors to seize the products, says CSPI.

None of the companies could provide CSPI investigators with any scientific studies that show that the products are effective. In response to emails, four companies claimed that studies existed but couldn’t provide any information about them, two companies stated that their evidence consisted of positive customer reviews, three companies conceded that they had no studies or offered no evidence, one company pointed to traditional use in China, and five companies failed to respond.

Many of the companies’ pills, which have names like EZ Quit, Kick It, Nicoban, and Vice Breaker, bear claims similar to those on FDA-approved prescription or over-the-counter smoking cessation products. EZ Quit claims that it “will help you to become smoke free immediately,” while Nicoban promises that “you will stop smoking in just 7 days.” And Vice Breaker tells consumers that they can “Quit smoking for the last time with minimal effort.” Some of the companies go so far as to compare their products favorably to FDA-approved products. EZ Quit, for instance, says that it “does the same thing as other pharmaceutical drugs on the market” and that there is “No need for patches, gums, lozenges.”

“Smoking is a leading cause of preventable death, and the FDA has approved prescription and over-the-counter products to help smokers quit,” said CSPI president Dr. Peter G. Lurie, who served as associate commissioner of the FDA from 2014 to 2017. “These dietary supplement manufacturers offer no evidence to back up their dramatic claims. If these products divert smokers from therapies that actually work and prolong their addiction to tobacco, they are doing real harm.”

A few of the supplements investigated by CSPI contain the herb lobelia. In 1993, the FDA banned over-the-counter lobelia-containing smoking cessation supplements for lack of evidence of effectiveness.

In a letter to Acting FDA Commissioner Ned Sharpless and other FDA officials, CSPI wrote that the supplements should qualify as an enforcement priority under the agency’s Health Fraud Compliance Policy Guide since the condition they purport to treat is significant, the scientific evidence is weak (and in the case of lobelia has been refuted by the FDA), those seeking treatment are numerous and vulnerable, and the supplements directly compete with FDA-approved treatments.

This isn’t the first time that CSPI has asked the FDA to take enforcement action against supplement manufacturers. In December 2017, the nonprofit group urged the FDA and the Federal Trade Commission to crack down on eight manufacturers of supplements marketed as opioid withdrawal aids which, like the smoking cessation supplements, had no evidence of effectiveness and bore claims similar to those on FDA-approved drugs. The following month, the agencies warned a dozen manufacturers of opioid withdrawal supplements, including six that had been named by CSPI, to stop marketing them.